MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	S02120-75
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascys0117 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after flushing the device, the small cap located between the two clamps on the extension tubing allegedly came off and the patient got blood and saline on their shirt and consequently, the system was open to air.Additional information received 8 jan 2021: it was reported the clamps were both clamped and a cap was put on the end to close it off.No patient harm was reported.

• Brand Name: MINILOC 20G X 0.75IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11241006
• Report Number: 3006260740-2021-00092
• Device Sequence Number: 14470313
• Product Code: FPA
• UDI-Device Identifier: 00801741087721
• UDI-Public: (01)00801741087721
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S02120-75
• Device Catalogue Number: S02120-75
• Device Lot Number: ASCYS0117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other